Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

Biosimilars 130

Biosimilars Drug Pricing 130

European Pharmaceutical Review

APRIL 11, 2024

percent CAGR between 2023 and 2032. Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. As of September 2022, there were around 39 biosimilars approved and 22 marketed, the report stated. million by 2032, at 17.6

Biosimilars 98

Biosimilars 98

European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

Biosimilars 88

Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 88

Big Molecule Watch

APRIL 19, 2024

launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported , Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations.

Biosimilars 62

Biosimilars 62

PharmaVoice

OCTOBER 24, 2022

In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

Biosimilars 203

Biosimilars 203

European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

Biosimilars 103

Biosimilars Immunity Immunization 103

Big Molecule Watch

JANUARY 18, 2024

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The Guide to Biosimilars Litigation and Regulation in the U.S.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

NOVEMBER 30, 2023

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Europe’s biosimilars market In Europe, Biocon Biologics portfolio includes seven biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab , Adalimumab , and Etanercept.

Biosimilars 101

Biosimilars 101

Express Pharma

DECEMBER 25, 2023

Intas Pharmaceuticals has signed an exclusive licensing agreement with mAbxience ( a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for biosimilar for Etanercept. According to IQVIA, global sales of Etanercept for 12 months ending June 2023 is $11B.

Biosimilars 105

Biosimilars 105

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Drug Channels

MARCH 28, 2023

Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. d/b/a Drug Channels Institute.

Biosimilars 95

Biosimilars 95

Big Molecule Watch

OCTOBER 11, 2023

FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). BI launched the product, marketed as CYLTEZO, in July 2023 at a 5% discount to HUMIRA.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

JULY 21, 2023

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. With this financial boost, the Ljubljana site is set to become a key location for biosimilar product development at Sandoz.

Biosimilars 93

Biosimilars Drug Development 93

LifeProNow

MARCH 24, 2023

March 21, 2023 : “Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz) injection. Head of North America. “As Head of North America.

Biosimilars 130

Biosimilars Immunity Immunization 130

Express Pharma

JUNE 22, 2023

Healthcare professionals (HCPs) believe that biosimilars could provide costs savings for the patients and healthcare systems and their use should be encouraged, according to a survey by GlobalData. The only exception was Japan were physicians seemed to be more reluctant about biosimilar use.

Biosimilars 98

Biosimilars 98

European Pharmaceutical Review

SEPTEMBER 11, 2023

has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). About the biosimilar development deal This agreement will help to expand access to biosimilar medicines , according to Samsung Bioepis. Samsung Bioepis Co.,

Biosimilars 78

Biosimilars 78

Express Pharma

DECEMBER 18, 2023

Over 10 emerging markets along with Japan, Australia and New Zealand have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris. Earlier in 2023, over 70 Emerging Markets were integrated in July, the North America business transitioned in September and the European business in November.

Biosimilars 105

Biosimilars 105

Big Molecule Watch

APRIL 22, 2024

On April 16, Alvotech and Teva announced the FDA approval of SELARSDI (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). SELARSDI is now the second ustekinumab biosimilar to be approved by the FDA, following FDA approval of Amgen’s WEZLANA (ustekinumab-auub) in October 2023.

Biosimilars 57

Biosimilars 57

European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

Biosimilars 84

Biosimilars 84

Drug Channels

JANUARY 10, 2023

For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products.

Biosimilars 92

Biosimilars 92

Safe Biologics

DECEMBER 1, 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines.

Drug Pricing 100

Drug Pricing Biosimilars 100

Pharmaceutical Commerce

NOVEMBER 8, 2023

Session explores how on-market products have done, and what to expect from new biosimilars.

Biosimilars 105

Biosimilars 105

Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived!

Biosimilars 78

Biosimilars Drug Pricing Labelling 78

Big Molecule Watch

FEBRUARY 1, 2024

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. FDA Accepts Accord BioPharma’s BLA for Ustekinumab Biosimilar On January 4, 2024, Accord BioPharma, Inc.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

DECEMBER 12, 2023

The first stage of construction has officially begun on Lek Pharmaceuticals’ new biologics and biosimilars production centre in Lendava, north eastern Slovenia. Sandoz announced plans for the facility in March 2023. The new biosimilars production centre will also include facilities for manufacturing and storage.

Biosimilars 97

Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. The 240,000 litre biomanufacturing plant was completed earlier in June 2023. “We

Biosimilars 96

Biosimilars 96

Pharmacy Times

NOVEMBER 3, 2023

On this month's episode, Pharmacy Times covers the Academy of Managed Care Pharmacy Nexus 2023 conference, highlighting the updates on biosimilars.

Biosimilars 52

Biosimilars 52

European Pharmaceutical Review

MAY 10, 2023

Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The company intends to grow its Biopharma Technical Development (BioTD) capabilities and transform the lab building into a state-of-the-art biotech lab by the last quarter of 2023.

Biosimilars 86

Biosimilars 86

Pharmaceutical Business Review

APRIL 5, 2024

The deal focuses on a biosimilar candidate currently in development for the treatment of multiple oncology indications. Biosimilars are gaining recognition for their potential to offer cost-effective alternatives to existing oncology therapies, which is crucial for enhancing global oncology care.

Biosimilars 59

Biosimilars 59

Big Molecule Watch

JULY 6, 2023

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there are now 8 adalimumab biosimilar products available in the U.S.

Biosimilars 67

Biosimilars 67

Express Pharma

AUGUST 1, 2023

The potential revenue replacing Humira has resulted in many adalimumab biosimilar offerings being brought forth (currently nine FDA-approved agents), and a rapidly overcrowded market. Against this backdrop, Cyltezo from Boehringer Ingelheim has shown the intersection of price and regulation in the biosimilar market, says GlobalData.

Biosimilars 98

Biosimilars 98

pharmaphorum

OCTOBER 2, 2023

Biogen claims first with FDA nod for biosimilar Actemra Phil.Taylor Mon, 02/10/2023 - 08:36 Bookmark this

Biosimilars 104

Biosimilars 104

pharmaphorum

SEPTEMBER 26, 2023

Polpharma Bio gets first EU okay for Tysabri biosimilar Phil.Taylor Tue, 26/09/2023 - 07:48 Bookmark this

Biosimilars 104

Biosimilars 104

Safe Biologics

NOVEMBER 12, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

Biosimilars 113

Biosimilars 113

Big Molecule Watch

MAY 19, 2023

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). On May 15, 2023, Boan Biotech announced the completion of patient enrollment for a Phase III clinical trial of the company’s Dulaglutide Injection (BA5101) in China.

Biosimilars 70

Biosimilars Diabetes 70